Sathish Kumar Balan
Senior Study Designer
Tambaram
Summary
Senior Study Designer with 8+ year of experience managing design process from protocol to production and post production. Trained and certified in Inform Central designer and Veeva Vault. Able to handle multiple studies simultaneously with stringed timelines and deliver with quality
Overview
11
11
years of professional experience
3
3
years of post-secondary education
Work History
Senior Study Designer
Accenture
Chennai
01.2015 - Current
- Lead the Designing, Programming and QC for Clinical Studies while helping client UAT the final Database design
- Designed more than 30 Alzhemier's, Epilepsy and oncology studies including Phase 1, Phase 2, Phase 3 studies and more than 80 Post production changes
- Provided orientation to other teams about the protocol and the database design such as Visits, Forms, Queries and Vendor Data
- Conducted impact analysis on post production requests and help the client in implementing the changes in the production database
- Managed multiple studies and Post production changes simultaneously while ensuring timely delivery of all deliverables with quality
- Create, Edit, Maintain and Archive multiple study documents with quality and completeness
- Mentored junior designers on how to effectively conduct and design a study from protocol till production
- Collaborating with the client and helping in creating standard eCRFs and Edit checks
- Presented Online Screen Review meetings to the client study team.
- Create and adjust timelines for studies as per the client requirements
Clinical Research Coordinator
Excel Life Sciences Pvt.Ltd
Noida, Delhi
05.2014 - 01.2015
- Followed participants through study activities to comply with study requirements.
- Developed effective working relationships with investigative sites, sponsors and CROs, IRBs, vendors and other stakeholders involved in clinical studies.
- Prepared periodic status reports summarizing key findings from ongoing studies for review by senior management.
- Ensured that all relevant regulatory documents were collected from investigative sites before initiating any study activities.
- Discussed research study with potential research participants.
- Responded to internal and external data queries and audit findings.
- Traveled to attend informational meetings regarding studies.
Clinical Research Associate
Quest Life Science Pvt.Ltd
Tambaram, Tamilnadu
11.2012 - 04.2014
- Ensuring that all bio-study related activities are recorded, conducted and reported in accordance with Standard Operating procedures (SOPs), Protocol, Good Clinical Practice (GCP), and the relevant regulatory requirements.
- Quality Control audit of study activities – audit of pre-study documents, online audit of study activities and audit of documents after the completion of the study.
- Coordination with Ethics committee for Protocol review and approval, submission of study updates and End of the study reports.
- Preparation of pre-study documents such as Synopsis, Check-in forms, Vacutainer labels in accordance with Protocol.
- To ensure all the activities are carried out in accordance with study Protocol. Preparing, modifying and review of Standard Operating procedures (SOPs).
Education
Post Graduate Diploma - Clinical Research
Focus Edu Care Pvt.Ltd
Chennai 08.2011 - 06.2012
Master of Science - Applied Microbiology
Hindustan College of Arts And Science
Padur, Kanchipuram 07.2009 - 04.2011
Skills
Project Management
Timeline
Senior Study Designer
Accenture
01.2015 - Current
Clinical Research Coordinator
Excel Life Sciences Pvt.Ltd
05.2014 - 01.2015
Clinical Research Associate
Quest Life Science Pvt.Ltd
11.2012 - 04.2014
Post Graduate Diploma - Clinical Research
Focus Edu Care Pvt.Ltd
08.2011 - 06.2012
Master of Science - Applied Microbiology
Hindustan College of Arts And Science
07.2009 - 04.2011
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